Twin Cities Chapter: Scaling a Human Factors Program According to a Medical Device’s Risk Profile an

Today, most medical device manufacturers have embraced human factors as both a regulatory and commercial imperative. There’s an understanding that human factors must be applied in the course of developing a Class II or Class III product, principally to (1) help ensure safe and effective use, and (2) meet FDA’s expectations and/or comply with IEC 62366-1. Manufacturers recognize that these consumer and software products have raised expectations among users that medical devices will be user-friendly.

Join professionals from your region to learn how manufacturers can scale their human factors work relative to a device’s class (I, II or II), the nature of the users (e.g., clinicians, laypersons) and the market (competitive, non-competitive.) Session attendees will come away with a firm idea of the scope of human factors work that is required to satisfy regulator’s expectations, as well as how much is optional and worthwhile to boost a device’s marketability.